REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia (RESEARCH-Pneumonia)

The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia
• Intervention / Treatment: Drug: TCM

Detailed Description

The incidence, hospitalization rate, and mortality associated with pneumonia are significant, contributing to a substantial disease burden. Post-discharge follow-up and intervention strategies for pneumonia patients are often insufficient, leaving patients vulnerable to readmission or mortality due to recurrent pneumonia and related complications. In clinical practice, there is a predominant focus on the amelioration of clinical symptoms during hospitalization, with limited attention to ongoing outpatient interventions aimed at reducing readmission rates. Consequently, there is a pressing need for cohort studies on pneumonia.

This study is a multicenter, prospective cohort study involving adult patients discharged after pneumonia treatment. Approximately 5,000 patients will be enrolled, with follow-up assessments conducted every three months over the course of one year. After one year, patients will be stratified into two cohorts based on the duration of Traditional Chinese medicine (TCM) treatment received (e.g., continuous treatment for two months or intermittent treatment for three months per year). One cohort will consist of patients receiving TCM, while the other will include those who did not receive TCM. The primary endpoint is the rate of hospital readmission, while secondary outcomes include treatment satisfaction, physician-reported outcomes, patient-reported outcomes, quality of life, nutritional status, incidence of acute upper respiratory tract infections, and survival. This study aims to evaluate the clinical efficacy and safety of TCM in the management of adult pneumonia patients following discharge.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Minghang Wang, Doctor; Phone Number: +86 371 66248624; Email: wmh107hn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients discharged after pneumonia.

Description

Selection Criteria:

• Hospitalized patients with a confirmed diagnosis of pneumonia (HAP, CAP).
• Age ≥18 years.
• Signed informed consent form.

Exclusion Criteria:

• Patients with confusion, consciousness disorders, dementia, and various mental illnesses;
• Patients with altered mental status, dementia, consciousness disorders, or various psychiatric conditions;
• Those who are completely unable to care for themselves or are bedridden long-term; and those currently participating in other clinical drug trials.
• Known to be allergic to treatment drugs.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TCM Group; The study will include adult patients discharged after hospitalization for pneumonia, with no restrictions on TCM syndromes. Patients diagnosed with pneumonia via laboratory or imaging tests at admission and treated in the hospital will be eligible if enrolled within seven days of discharge. Follow-ups will occur every three months over one year, documenting treatment methods (TCM or Western medicine), hospitalizations, respiratory infections, mortality, and quality of life. Subgroup analyses will be conducted based on age, type of pneumonia (community- or hospital-acquired), specific TCM treatments (e.g., Chinese patent medicines or external therapies), and treatment duration.	Drug: TCM; We will perform subgroup analyses based on specific TCM interventions (such as Chinese patent medicines or external therapies) and the duration of TCM treatment (for example, comparing patients who receive continuous oral Chinese patent medicine for two months or more each year with those who do not). These analyses will assess the efficacy and safety of TCM.
Non-TCM Group; All patients who do not meet the defined criteria for the TCM group will be classified into the non-TCM group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehospitalization rate	Including all-cause readmission rate and pulmonary infection readmission rate	The Rehospitalization rate within a one-year follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with efficacy	The Effectiveness Satisfaction Questionnaire of CAP (ESQ-CAP) was used to evaluate the efficacy of pneumonia patients.	Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Health survey summary table（SF-36）	Using SF-36 to evaluate the impact of CAP on a person's life over time	Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Clinical outcomes reported by patients	The Patient Reported Outcome for CAP (CAP-PRO) was used to assess the quality of life and health status of patients with pneumonia.	Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Clinical outcomes reported by doctors	The Clinical Reported Outcome for CAP (CAP CRO) was used to assess the patient's condition.	Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
nutritional status	Nutritional status related indicators.	Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage
Acute upper respiratory tract infection (URTI) event	It is a general term for acute inflammation of the nose, pharynx, or throat caused by various viruses and/or bacteria, including common cold, acute viral pharyngitis or laryngitis, acute herpetic pharyngitis, pharyngoconjunctival fever, bacterial pharyngitis, and tonsillitis.	Acute upper respiratory tract infection events that occurred during the one-year follow-up period
Survival situation	Record the number of deaths. Record the follow-up period every 3 months.	Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Collaborators: Shanghai University of Traditional Chinese Medicine; Shaanxi Hospital of Traditional Chinese Medicine; Wuhan No.1 Hospital; The First Affiliated Hospital of Zhejiang Chinese Medical University; Qingdao Hiser Medical Group; Hebei Provincial Hospital of Traditional Chinese Medicine
• Investigators: Study Chair: Jiansheng Li, Doctor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 26, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pneumonia; Cohort; Chinese Medicine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Lung Diseases; Pneumonia; Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: RESEARCH-Pneumonia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO